Recently, Allos Therapeutics, Inc. (ALTH) announced encouraging survival data from a mid-stage study of its cancer drug Folotyn (pralatrexate injection). The randomized study (n=201) evaluated the efficacy of Folotyn against Roche’s (RHHBY) erlotinib (Tarceva) in patients suffering from advanced non-small cell lung cancer (NSCLC) who are, or have been, cigarette smokers and did not respond to chemotherapy.
Results from the study, presented at the European Society of Medical Oncology, revealed that treatment with Folotyn reduced the risk of death by 16% in patients suffering from non-small cell lung cancer when compared with patients taking only Tarceva. Initial data from this study, which enrolled patients from 43 sites across the globe, was presented in July this year.
The study revealed favorable survival patterns for patients treated with Allos’ therapy as against those treated with Tarceva. 28% of the NSCLC patients treated with Folotyn survived for at least 12 months as opposed to 18% in the Tarceva arm (the corresponding figures were 56% and 51% respectively in the two arms at six months).
The most encouraging result came from the group consisting of patients suffering from non-squamous cell carcinoma (n=107), a common form of non-small cell lung cancer. They experienced a 35% reduction in the risk of death and 42% drop in the risk of disease progression.
However, the median duration of overall survival was slightly lower in patients treated with Folotyn. They lived for a median of 6.7 months as opposed to 7 months for patients in the Tarceva arm.
Our Take & Recommendation
We note that Allos’ future is dependent on Folotyn. The drug is approved in the US for treating patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). We believe Folotyn’s approval for the PTCL indication will provide major relief to patients suffering from this disease as prior to Folotyn there was no approved drug. While the drug has been available to patients since October 2009, it was launched commercially in January 2010.
The company’s efforts to expand Folotyn’s label into other indications is encouraging. We believe that Folotyn, if approved for any of the additional indications, can prove to be a major revenue generator for the company.
Currently, we are Neutral on Allos Therapeutics supported by a Zacks #3 Rank (short-term ‘Hold’ recommendation).
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